TraumatologyNCT07012850
Advanced Magnetic Resonance Imaging for Perioperative Evaluation of Dental, Oral and Maxillofacial Trauma
An observational study of Traumatology and Maxillofacial Trauma, run by Harald Essig at 1 site in Switzerland.
Trial summary
Dental, oral, and maxillofacial trauma represents a significant public health concern, with most cases resulting from accidents and occurring frequently in young adults. Diagnosis relies on clinical examination and imaging modalities like computed tomography (CT) and cone-beam computed tomography (CBCT), which are… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Traumatology, Maxillofacial Trauma, Maxillofacial Injuries
- What is being tested?
- Magnetic Resonance Imaging
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 May 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study Population from the University Hospital Zurich, Switzerland
Who may be able to join
- Patients presenting with acute dental, oral and maxillofacial trauma
- Age: 18 years and older
- Able to give informed consent (documented by signature)
- No prior radiation-based imaging for the current trauma episode
Who cannot join
- Pregnant or lactating individuals
- Known contraindications to MRI (e.g., pacemakers, certain implants)
- Clinically significant concomitant diseases affecting imaging quality (e.g., severe neurocognitive disorders)
- Inability to comply with MRI procedures or study protocol (e.g., due to language barriers, psychological disorders, or dementia)
- Participation in other clinical trials that may interfere with the imaging study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Department of Cranio-Maxillofacial and Oral Surgery, University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
Dental, oral, and maxillofacial trauma represents a significant public health concern, with most cases resulting from accidents and occurring frequently in young adults. Diagnosis relies on clinical examination and imaging modalities like computed tomography (CT) and cone-beam computed tomography (CBCT), which are standard for hard tissue assessment but expose patients to ionizing radiation. To reduce radiation exposure while simultaneously allowing for the visualization of soft tissues, newer imaging methods, including magnetic resonance imaging (MRI), as well as Black Bone and CT-like MRI protocols (ZTE, UTE), are being explored. These MRI techniques offer high-resolution, non-ionizing alternatives, showing promise for diagnosing soft tissue injuries and fractures without radiation risks, especially beneficial for younger patients. This study aims to assess MRI's diagnostic capabilities for maxillofacial trauma, focusing on early diagnosis, artifact reduction, and comparison to conventional X-ray-based imaging, within a minimal-risk study framework.
This study aims to evaluate the diagnostic efficacy of MRI compared to X-ray-based imaging modalities (CT/CBCT) for detecting dental, oral, and maxillofacial fractures, with a specific focus on Black Bone and CT-like MRI techniques. Additionally, it investigates MRI's potential to reduce artifacts around osteosynthesis plates, enhancing postoperative imaging quality in the presence of metal hardware.
- Conditions
- Traumatology, Maxillofacial Trauma, Maxillofacial Injuries
- Being tested
- Magnetic Resonance Imaging
- Medical subject headings
- Maxillofacial Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDiagnostic test
To reduce radiation exposure while simultaneously allowing for the visualization of soft tissues, newer imaging methods, including magnetic resonance imaging (MRI), as well as Black Bone and CT-like MRI protocols (ZTE, UTE), are being explored. These MRI techniques offer high-resolution, non-ionizing alternatives, showing promise for diagnosing soft tissue injuries and fractures without radiation risks.
What is being measured
The primary outcome is the main question the study is designed to answer.
qualitative imaging parameters
Primary Outcome Measures:
- Qualitative Assessment of Imaging Quality
Description: Image quality will be evaluated using a standardized 5-point Likert scale for the following parameters: overall image quality, artifact severity, fracture visibility, and bone-to-soft-tissue contrast. Each parameter will be scored independently.
Unit of Measure: Score on a 5-point Likert scale (1 = poor, 5 = excellent)
Measured: From enrollment to the end of treatment at week 5
Quantitative Assessment of Fracture Dimensions
Fracture length, width, and depth will be measured in millimeters across axial, sagittal, and coronal planes using standardized digital radiologic tools. Measurements will be taken by two blinded radiologists and averaged.
Unit of Measure: Millimeters (mm).
Measured: From enrollment to the end of treatment at week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start5 May 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TraumatologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harald Essig
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Harald Essig, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012850
- Sponsor's protocol ID
- 2024-02307
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al-Haj Husain A, Sandhu S, Burian E, Precht MM, Sommer S, Frauenfelder T, Wagner MEH, Essig H. Intraoperative C-arm CBCT versus early postoperative MRI for the assessment of fracture reduction and osteosynthesis material positioning in cranio-maxillofacial trauma surgery. Oral Maxillofac Surg. 2026 Jun 26;30(1):101. doi: 10.1007/s10006-026-01588-8.
PubMed 42360559Al-Haj Husain A, Kessler P, Lie SAN, Sandhu S, Wagner MEH, Burian E, Zedler D, Precht MM, Sommer S, Frauenfelder T, Essig H. Comparative evaluation of MRI-based bone-targeted sequences and computed tomography for preoperative assessment of midfacial trauma. Sci Rep. 2026 Feb 18;16(1):9700. doi: 10.1038/s41598-026-40252-9.
PubMed 41708704Al-Haj Husain A, Sandhu S, Wagner MEH, Burian E, Lie SAN, Precht MM, Zedler D, Frauenfelder T, Hotker AM, Stadlinger B, Sommer S, Kessler P, Essig H. Diagnostic performance of CT and MRI in mandibular trauma assessment - a prospective comparative study. Oral Maxillofac Surg. 2025 Dec 27;30(1):12. doi: 10.1007/s10006-025-01496-3.
PubMed 41454981
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Magnetic Resonance Imaging for Perioperative Evaluation of Dental, Oral and Maxillofacial Trauma
- ClinicalTrials.gov ID
- NCT07012850
- Acronym / sponsor ID
- 2024-02307
- Conditions
- Traumatology, Maxillofacial Trauma, Maxillofacial Injuries
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Harald EssigUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dental, oral, and maxillofacial trauma represents a significant public health concern, with most cases resulting from accidents and occurring frequently in young adults. Diagnosis relies on clinical examination and imaging modalities like computed tomography (CT) and cone-beam computed tomography (CBCT), which are standard for hard tissue assessment but expose patients to ionizing radiation. To reduce radiation exposure while simultaneously allowing for the visualization of soft tissues, newer imaging methods, including magnetic resonance imaging (MRI), as well as Black Bone and CT-like MRI protocols (ZTE, UTE), are being explored. These MRI techniques offer high-resolution, non-ionizing alternatives, showing promise for diagnosing soft tissue injuries and fractures without radiation risks, especially beneficial for younger patients. This study aims to assess MRI's diagnostic capabilities for maxillofacial trauma, focusing on early diagnosis, artifact reduction, and comparison to conventional X-ray-based imaging, within a minimal-risk study framework.
This study aims to evaluate the diagnostic efficacy of MRI compared to X-ray-based imaging modalities (CT/CBCT) for detecting dental, oral, and maxillofacial fractures, with a specific focus on Black Bone and CT-like MRI techniques. Additionally, it investigates MRI's potential to reduce artifacts around osteosynthesis plates, enhancing postoperative imaging quality in the presence of metal hardware.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study Population from the University Hospital Zurich, Switzerland
Key inclusion criteria (4 listed)
- Patients presenting with acute dental, oral and maxillofacial trauma
- Age: 18 years and older
- Able to give informed consent (documented by signature)
- No prior radiation-based imaging for the current trauma episode
Key exclusion criteria (5 listed)
- Pregnant or lactating individuals
- Known contraindications to MRI (e.g., pacemakers, certain implants)
- Clinically significant concomitant diseases affecting imaging quality (e.g., severe neurocognitive disorders)
- Inability to comply with MRI procedures or study protocol (e.g., due to language barriers, psychological disorders, or dementia)
- Participation in other clinical trials that may interfere with the imaging study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingTo reduce radiation exposure while simultaneously allowing for the visualization of soft tissues, newer imaging methods, including magnetic resonance imaging (MRI), as well as Black Bone and CT-like MRI protocols (ZTE, UTE), are being explored. These MRI techniques offer high-resolution, non-ionizing alternatives, showing promise for diagnosing soft tissue injuries and fractures without radiation risks. | Diagnostic test | – |
Primary outcome
qualitative imaging parameters
Time frame: From enrollment to the end of treatment at week 5
Primary Outcome Measures: 1. Qualitative Assessment of Imaging Quality Description: Image quality will be evaluated using a standardized 5-point Likert scale for the following parameters: overall image quality, artifact severity, fracture visibility, and bone-to-soft-tissue contrast. Each parameter will be scored independently. Unit of Measure: Score on a 5-point Likert scale (1 = poor, 5 = excellent)
Quantitative Assessment of Fracture Dimensions
Time frame: From enrollment to the end of treatment at week 5
Fracture length, width, and depth will be measured in millimeters across axial, sagittal, and coronal planes using standardized digital radiologic tools. Measurements will be taken by two blinded radiologists and averaged. Unit of Measure: Millimeters (mm).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Derived from this study: PubMed 42360559Al-Haj Husain A, Sandhu S, Burian E, Precht MM, Sommer S, Frauenfelder T, Wagner MEH, Essig H. Intraoperative C-arm CBCT versus early postoperative MRI for the assessment of fracture reduction and osteosynthesis material positioning in cranio-maxillofacial trauma surgery. Oral Maxillofac Surg. 2026 Jun 26;30(1):101. doi: 10.1007/s10006-026-01588-8.
- Derived from this study: PubMed 41708704Al-Haj Husain A, Kessler P, Lie SAN, Sandhu S, Wagner MEH, Burian E, Zedler D, Precht MM, Sommer S, Frauenfelder T, Essig H. Comparative evaluation of MRI-based bone-targeted sequences and computed tomography for preoperative assessment of midfacial trauma. Sci Rep. 2026 Feb 18;16(1):9700. doi: 10.1038/s41598-026-40252-9.
- Derived from this study: PubMed 41454981Al-Haj Husain A, Sandhu S, Wagner MEH, Burian E, Lie SAN, Precht MM, Zedler D, Frauenfelder T, Hotker AM, Stadlinger B, Sommer S, Kessler P, Essig H. Diagnostic performance of CT and MRI in mandibular trauma assessment - a prospective comparative study. Oral Maxillofac Surg. 2025 Dec 27;30(1):12. doi: 10.1007/s10006-025-01496-3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatology and Maxillofacial Trauma, run by Harald Essig at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
qualitative imaging parameters (time frame: From enrollment to the end of treatment at week 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07012850, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.